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Completed

NCT Number: NCT03297827

Cytokine Registry Database of Stroke Patients

Various molecules (cytokines: interleukins, interferons and neural proteins) found in human and animal blood are reported to be elevated in acute stroke (Ischemic and hemorrhagic). Cytokines can be pro-inflammatory or anti-inflammatory. There are studies confirming level changes in serum of humans in the setting of several rheumatologic and cardiovascular diseases. As new molecular markers (cytokines and neural tissue markers) are established in scientific literature, stroke scientists are interested to evaluate the role of these in the pathophysiology of stroke. Investigators intend to study the role of these molecules in the development of stroke.

Acute stroke treatment has advanced considerably in the last 10 years with the establishment of comprehensive stroke centers and approval of neuro-interventional techniques. However, the molecular advancement in stroke pathogenesis has yet to reach a milestone in the world of stroke treatment. In our opinion, creating a database of acute stroke patients containing all pertinent medical demographics and clinical information along with the laboratory data, molecular levels of pertinent cytokines/neural factors from consenting patients, will help us define and delineate the most relevant molecules that are altered in acute stroke patients and can help us further improve us understanding of the role of these in acute stroke and thereby hopefully help in the improvement of our understanding and management of stroke. Moreover, analyzing the cytokines in stroke and ICH patients would help understand their role in the acute phase, which may become potential therapeutic adjuncts for tPA and endovascular thrombectomy.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurology, University of New Mexico

Albuquerque, New Mexico, 87131-0007, United States

About this study

Stroke is the fifth cause of all-cause mortality in US http://www.cdc.gov/stroke/facts.htm . Early identification and treatment not only prevent mortality but also morbidity. Recent advancement in the imaging and diagnostic technique and novel therapeutic modalities has dramatically helped to downgrade stroke from the list of top mortality index in the last 3 years. However, studies determining factors which help predict stroke outcome are still underway and much work needs to be done in this direction. Many factors currently are used to predict stroke outcome with varying results, for e.g. NIHSS is a good predictor of stroke outcome at 3 months; however, we need better predictors, outcome scales or outcome measures which are easy, reliable and has better specificity and sensitivity.

There is also some correlation of clinical and biochemical predictors in subarachnoid, cerebral venous thrombosis including Hunt and Hess, SAH score, WFNS-SAH grading among others with variable predictive quality. (Rosen et al; Neurocritical Care; April 2005, Volume 2, Issue 2, pp 110- 118: Subarachnoid hemorrhage grading scales).

During the acute phase of focal cerebral ischemia, there is an elevation of thrombin activity and a decline in fibrinolytic activity. Moreover, the role of pro-inflammatory cytokines has been proven in the last few decades, as markers of inflammation have been closely studied in mice models; there are indications that elevated levels correlate with the extent of ischemic injury. Various interleukins were found to be elevated in most if not all patients with acute ischemic stroke. Correlation of hemostatic (procoagulant and fibrinolytic markers) with inflammatory markers is under discussion, with no confirmed common marker identified as of yet.

As new cytokines and tissue markers are established in scientific literature, stroke scientists are interested in evaluating the role of these markers in the pathophysiology of stroke. The role of glial cell markers has been of remarkable interest. Recently, an astrocyte marker S100B has shown association with infarct size, neurological outcome, and prognosis. Moreover, analyzing the cytokines in stroke and ICH patients would help understand their role in the acute phase, which may become potential therapeutic adjuncts for tpa and endovascular thrombectomy. In summary, inflammation in acute stroke is an area of interest in the recent years, with the theoretical benefit of aborting the inflammatory chain during acute stroke might be useful in limiting stroke-related brain damage or hemorrhagic transformation in acute stroke.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All stroke patients (hemorrhagic and ischemic) presenting within 24 hours of onset who consent to our study.
  • Adult Male/Female patients ages >18 years old
  • Patients whose standard stroke admission order sets are obtained for clinical care.
  • Patients with a history of MS may be included for future subanalysis.

Exclusion criteria

  • History of prior stroke or any other neurodegenerative or neuroinflammatory disease (AD, PD, TM, PSP, etc.) except MS.
  • Individuals ages <18 year
  • Pregnant women
  • Prisoners

Treatment and study plan

Serum and Urine measurement of cytokines.

Other

To evaluate serum cytokine levels and identifying serum inflammatory markers (serum interleukin-33, IL-37, IL-36, IL-4, IL-6, IL-10, IL-17, IL-23, IL-1, TNF, PDGF, VEGFM TNFa, ANNULIN, MMP-9, MMP-12, NFk-B levels plus metabolic products like MPO, etc and glial factors like GMF, SI000B, GM6001) in patients with acute ischemic & hemorrhagic stroke.

Primary outcomes

  1. Change in the cytokine levels at the 24-hour mark from the baseline levels done at the time of admission for acute stroke.

    Time frame: 24 Hours

    Investigators will assess the variations in the levels of cytokines and inflammatory biomarkers at the 24-hour mark from the baseline levels done at the time of admission for acute stroke. Their correlation with each other may enable investigators to identify and streamline their efforts on only a few cytokines, interleukins, glial factors or metabolic products proved to be altered in acute stroke patients.

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Registry information

Official study title

A Prospective Cytokine Registry Database of Stroke (Ischemic and Hemorrhagic) Patients.

Acronym: CRISP

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 29, 2017
Registry last updated
Feb 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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